Lung Cancer Screening Decisions (VA-LCSDecTool)
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|ClinicalTrials.gov Identifier: NCT02899754|
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2020
Veterans have a high risk of developing lung in comparison to general populations due to their older age and smoking history. Recent evidence indicates that lung cancer screening with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the rates of false positive findings are high, requiring further testing and evaluation. Preliminary studies report that while some Veterans are enthusiastic about screening, others are highly reluctant. Patient preferences should be considered as part of an informed decision making process for this emerging paradigm of lung cancer control. Effective methods for preference assessment among Veterans have not yet been developed, evaluated, and integrated into clinical practice. The specific aims of this study are to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of life.
(5/8/18)-This project involves the recruitment of both Veterans as well as health care providers/leaders. Patient recruitment efforts at both sites will target male and female patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients, and 10% women.
(10/25/2018) Patient recruitment efforts at both sites will target male and female To Date, 32 Veterans have signed the consent form and completed their portion of the trial (16 at CMCVAMC and 16 at West Haven, CT). To Date, 61 Providers have completed their portion of the trial (18 at CMCVAMC and 43 at West Haven, CT). Enrollment for Phase 1 is complete. Enrollment for Phase 2 will begin in June, 2018.patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients, and 10% women. To Date, 9 Veterans have signed the consent form and completed their portion of the trial (9 at CMCVAMC and 0 at West Haven, CT). Enrollment for Phase 2 is ongoing with the intent to complete By November 30, 2018.
(01/15/2019) Phase 2 patient recruitment is complete. 18 Veterans have signed the consent form and completed their portion of the trial (12 at CMCVAMC and 6 at West Haven, CT). 14 Providers have completed their portion of the trial (8 at CMCVAMC and 6 at West Haven, CT). Enrollment for Phase 3 will begin in February, 2019.
To Date (7/1/2019) Enrollment for Phase 3 is ongoing with the intent to complete by February 28, 2020. To Date, 18 Veterans have signed the consent form and completed their baseline portion of the trial (18 at CMCVAMC and 0 at West Haven, CT).
To Date (12/3/2019) Enrollment for Phase 3 is ongoing with the intent to complete by February 28, 2021. A 1-year study extension has been submitted and awaiting approval. To Date, 70 Veterans have signed the consent form and completed their baseline portion of the trial (65 at CMCVAMC and 5 at West Haven, CT).
To Date (9/9/2020) Enrollment for Phase 3 has just resumed after being placed on administrative hold since March 2020 due to Covid-19. Secondary Site in West Haven, CT has been replaced by Milwaukee, WI. To Date, 90 Veterans have signed the consent form and completed their baseline portion of the trial (83 at CMCVAMC, 5 at West Haven, CT and 2 at Milwaukee, WI).
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Screening||Behavioral: Lung Cancer Screening Decision Tool Behavioral: Control Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Incorporating Veterans Preferences Into Lung Cancer Screening Decisions|
|Actual Study Start Date :||January 28, 2019|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||February 28, 2021|
Experimental: Intervention Group
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Behavioral: Lung Cancer Screening Decision Tool
This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
Other Name: LCSDecTool
Active Comparator: Control Group
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Behavioral: Control Intervention
This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
Other Name: Control
- Decision Regret [ Time Frame: 1 month following intervention ]Decision regret as measured by a 5-item Decision Regret scale that is patient reported.
- Decisional Conflict [ Time Frame: 1 month following the intervention ]Decisional conflict as measured by a 16 item Decisional Conflict scale that is patient reported
- Anxiety [ Time Frame: 1 month following intervention ]State anxiety as measured by the State Trait Anxiety Index
- Lung cancer worry [ Time Frame: 1 month after the intervention ]Lung cancer worry as measured by a 7 item scale that is patient reported
- Lung cancer screening uptake [ Time Frame: 6 months after the intervention ]Assessed by chart review
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899754
|Contact: Marilyn M Schapira, MD MPH||(215) 823-5800||Marilyn.Schapira@va.gov|
|Contact: Jason Prigge, BS MS||(215) 823-5800 ext 3883||Jason.Prigge@va.gov|
|United States, Connecticut|
|VA Connecticut Healthcare System West Haven Campus, West Haven, CT||Active, not recruiting|
|West Haven, Connecticut, United States, 06516|
|United States, Pennsylvania|
|Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Kimberly M Brown, PhD 215-823-5800 ext 6248 Kimberly.Brown6@va.gov|
|Principal Investigator: Marilyn M. Schapira, MD MPH|
|United States, Wisconsin|
|Clement J. Zablocki VA Medical Center, Milwaukee, WI||Recruiting|
|Milwaukee, Wisconsin, United States, 53295-1000|
|Contact: Jeffrey Whittle, MD 414-384-2000 ext 46444 Jeffrey.Whittle@va.gov|
|Contact: Julie Rieder 414-384-2000 ext 46628 Julie.Rieder@va.gov|
|Principal Investigator:||Marilyn M. Schapira, MD MPH||Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA|
|Principal Investigator:||Jeffrey C Whittle, MD MPH||Clement J. Zablocki VA Medical Center, Milwaukee, WI|